Court Decision Raps FDA’s Handling of Plan B Contraceptive

A federal court ruling that overturned some age limits on over-the-counter sales of the morning-after contraceptive Plan B slammed several current and former officials with the FDA, including the current acting Surgeon General. The WSJ reports on ruling this morning.

Dr. Steven Galson, who was named acting Surgeon General in 2007 and is also acting assistant secretary for Health and Human Services, was criticized by Judge Edward Korman of the Eastern District of New York. In a 52-page decision handed down yesterday, the judge said Galson bowed to the Bush administration and its “constituents.”

“The pressure coming from the White House appears to have been transmitted down by the Commissioner’s office in such a way as to significantly affect Dr. Galson’s position on the over-the-counter switch application,” wrote Korman, who went on to detail the contacts between the White House and FDA leaders.

The judge cited a deposition by Galson’s then–deputy John Jenkins, who now runs the FDA’s drug-approval office, that portrayed Galson as worried about keeping his job as acting chief of the Center for Drug Evaluation and Research at the time.

Jenkins testified that “there were occasions where … Dr. Galson … told me that he felt that he didn’t have a choice, and … that he wasn’t sure that he would be allowed to remain as Center Director if he didn’t agree with” a 2004 decision to delay approval of the pills, which were made Barr Pharmaceuticals, now a unit of Teva.

After Galson finally did decide to draft a letter to Barr allowing over-the-counter sales for those 17 and older — the White House and conservatives didn’t want OTC sales approved for any age — Galson’s authority to approve the limited sales was taken away by the then-FDA Commissioner Lester Crawford. The FDA’s 2006 approval of Plan B’s sales without a prescription soon led to a doubling of its sales.

The judge also said the only two times the FDA moved forward on Plan B were when Senate Democrats held up FDA commissioner confirmation votes, such as the one for Andy von Eschenbach in 2006, which was held being hostage at the time by Hillary Clinton of New York and Patty Murray of Washington. And the judge basically agreed with some agency employees’ testimony that FDA officials had stacked an advisory committee to debate the safety of Plan B for over-the-counter sales with people from the “Right to Life antiabortion world.” The panel voted 23-4 in favor of the drug, anyway.

Korman’s ruling cold provide fodder for the Obama White House, which has been on a campaign about the importance of scientific integrity. The decision could also be taken to aid FDA whistleblowers and critics, including the omnipresent Sen. Chuck Grassley, who have complained of cases where they say the FDA trashes science for politics and that advisory committees named by the agency are sometimes stacked.

The administration didn’t make Galson available for comment. Korman, by the way, is a Reagan appointee.

Comments (5 of 5)

This false 'battle' between science and politics really bugs me. Policy, any governemtn policy, IS POLITICAL. All science can do is bring evidence to the political debate; after that its all politics. The decision to use federal dollars on hESC research isn't politics vs. science, its politics applied to science funding. There is nothing that science can say which makes federal funding for any given program more or less scientific. The same with the FDA: they are supposed to interpret evidence and make decisions based on their legal authority, what the FDA is NOT supposed to do is ask all the scientists how they think the world should work and run the world accordingly.

The notion of an impartial, scientific bureaucracy running DC is a fantasy; the truth is the the science is 'clear and unbiased' when it agrees with your politics and the committee is stacked with political hacks when you disagree.

5:12 pm March 24, 2009

Look who is talking 4:59 wrote :

This issue has nothing to do with partisanship and everything to do with science vs. ideology. Today science won.
Kudos to you for furthering mindless partisanship.

4:59 pm March 24, 2009

David wrote :

What 4:26 pm said is a typical nonsense from liberals: we are not doing well to limit illegal immigrants so we should give them citizenship. Using same logic, we should not consider killing or rape as crime because no matter how hard we punish, these activities still exist. Likewise, we shouldn't ban any drugs since some people will use illegal drugs anyway.
I really appreciate what Ann says: if a democrat can think, he/she will be a republican.

4:26 pm March 24, 2009

Healthcare Guru wrote :

what we have forgotten is the availability or lack of it does not change people's behaviour as they will find alternative ways.

SO, the option is to focus more on education so that they do not have the need for it. It has to be a mixture of persuation and education. If it was possible to change people's behaviour simply by legislation, we would not have the crimes as much as we see.